Atlas CRP Latex Kit, 100 Tests (4ml Latex, 1x0.5ml Positive Control, 1x0.5ml Negative Control, 1x10ml Buffer (20X), Glass Slide, Stirring Sticks).
Ref 8.00.01.4.0100
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-04262408510086 04262408510086 | Date22 Jul 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- 8.00.01.4.0100
- Primary DI / UDI-DI
- 04262408510086
- Basic UDI-DI
- B-04262408510086
- EMDN Code
- W01021109 C-reactive protein
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000029961
Other devices from Atlas Medical GmbH
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No